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| ID | Type | Description | Link |
|---|---|---|---|
| ART-01 | Other Identifier | Eli Lilly and Company |
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To assess the efficacy and safety of LY2951742 in the prevention of migraine headache in migraineurs with or without aura during 3 months of treatment.
The study is comprised of 4 trial periods:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY2951742 | Experimental | LY2951742: 150 milligrams (mg), subcutaneous (SC) injection on Day 1 and then once every other week for a total of 6 doses during the 12-week Treatment Period. |
|
| Placebo | Placebo Comparator | Placebo: 0.9% Sodium Chloride, Untied States Pharmacopoeia (USP), subcutaneous (SC) injection on Day 1 and then once every other week for a total of 6 doses during the 12-week Treatment Period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2951742 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in the Number of Migraine Headache Days in the Last 28-day Period of the 12-week Treatment Phase | The criteria for a migraine headache was adapted from the standard International Headache Society (IHS) International Classification of Headache Disorders II guidelines 1.1 and 1.2 (ICHD-II, Cephalgia 2004). The definition of a migraine headache was a headache with or without aura, of ≥30 minutes (min) duration, and with both ("A" and "B") required features from the IHS ICHD-II definition. Required feature "A" includes at least 2 of the following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature "B" includes at least 1 of the following during the headache: nausea and/or vomiting, or photophobia and phonophobia. Least square (LS) means were calculated using mixed model repeated measures (MMRM) with baseline value, treatment, month, and treatment-by-month interaction as fixed effects and participant as random effect. | Baseline, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in the Number of Headache Days in the Last 28-day Period of the 12-week Treatment Phase | Number of calendar days on which a headache lasts ≥4 hours which includes migraines, probable migraines (PM) and nonmigraines. Criteria for migraine headache (MH) was adapted from standard IHS ICHD-II guidelines 1.1 and 1.2 (Cephalgia 2004). Definition of MH was headache with or without aura, of ≥30 min duration, and with both ("A" and "B") required features from IHS ICHD-II definition. Required feature "A" includes ≥2 of following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature "B" includes at least 1 of following during headache: nausea and/or vomiting, or photophobia and phonophobia. PM is headache with or without aura, but missing 1 feature needed to fulfill all criteria for MH. LS means were calculated using MMRM with baseline value, gender, treatment, month, and treatment-by-month interaction as fixed effects and participant as random effect. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neurological Physicians of Arizona / Clinical Research Advantage | Gilbert | Arizona | 85234 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32576229 | Derived | Stauffer VL, Turner I, Kemmer P, Kielbasa W, Day K, Port M, Quinlan T, Camporeale A. Effect of age on pharmacokinetics, efficacy, and safety of galcanezumab treatment in adult patients with migraine: results from six phase 2 and phase 3 randomized clinical trials. J Headache Pain. 2020 Jun 23;21(1):79. doi: 10.1186/s10194-020-01148-9. | |
| 31004075 |
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| ID | Title | Description |
|---|---|---|
| FG000 | LY2951742 | LY2951742: 150 milligrams (mg), subcutaneous (SC) injection on Day 1 and then once every other week for a total of 6 doses during the 12-week Treatment Period. |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Baseline, 12 weeks |
| Mean Change From Baseline in the Number of Migraine Attacks in the Last 28-day Period of the 12-week Treatment Phase | A migraine attack was defined as beginning on any day a migraine headache day was recorded and ending when a migraine headache-free day occurred. The criteria for a migraine headache was adapted from the standard IHS ICHD-II guidelines 1.1 and 1.2 (Cephalgia 2004). The definition of a migraine headache was a headache with or without aura, of ≥30 minutes duration, and with both ("A" and "B") required features from the IHS ICHD-II definition. Required feature "A" includes at least 2 of the following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature "B" includes at least 1 of the following during the headache: nausea and/or vomiting, or photophobia and phonophobia. LS means were calculated using MMRM with baseline value, gender, treatment, month, and treatment-by-month interaction as fixed effects and participant as random effect. | Baseline, 12 weeks |
| Percentage of Responders | Percentage of participants with greater than 50% reduction in the number of migraine headache days in a 28-day period. The criteria for a migraine headache was adapted from the standard International Headache Society (IHS) International Classification of Headache Disorders II guidelines 1.1 and 1.2 (ICHD-II, Cephalgia 2004). The definition of a migraine headache was a headache with or without aura, of ≥30 minutes duration, and with both ("A" and "B") required features from the IHS ICHD-II definition. Required feature "A" includes at least 2 of the following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature "B" includes at least 1 of the following during the headache: nausea and/or vomiting, or photophobia and phonophobia. | Baseline, 4, 8, and 12 weeks |
| Arizona Research Center |
| Phoenix |
| Arizona |
| 85023 |
| United States |
| Mayo Foundation for Medical Education and Research - Mayo Clinic | Scottsdale | Arizona | 85259 | United States |
| PRI Encino | Encino | California | 91316 | United States |
| Allergy and Asthma Specialists Medical Group | Huntington Beach | California | 92647 | United States |
| Collaborative Neuroscience Network Inc. | Long Beach | California | 90806 | United States |
| PRI Los Alamitos | Los Alamitos | California | 90720 | United States |
| PRI Newport Beach | Newport Beach | California | 92660 | United States |
| Medical Center for Clinical Research | San Diego | California | 92108 | United States |
| Artemis Institute for Clinical Research | San Diego | California | 92123 | United States |
| San Francisco Clinical Research Center | San Francisco | California | 94109 | United States |
| University of California, San Francisco (UCSF) Medical Center - Headache Center | San Francisco | California | 94115 | United States |
| California Medical Clinic for Headache Inc | Santa Monica | California | 90404 | United States |
| Radiant Research - Denver | Denver | Colorado | 80239 | United States |
| Florida Clinical Research Center LLC | Maitland | Florida | 32751 | United States |
| Accelovance, Inc | Melbourne | Florida | 32935 | United States |
| Renstar Medical Research | Ocala | Florida | 34471 | United States |
| Broward Research Group | Pembroke Pines | Florida | 33026 | United States |
| Neurology Clinical Research Inc | Sunrise | Florida | 33351 | United States |
| MedVadis Research | Watertown | Massachusetts | 02472 | United States |
| Westside Family Medical Center, PC | Kalamazoo | Michigan | 49009 | United States |
| Ryan Headache Center, St. John's Mercy Medical Group | Chesterfield | Missouri | 63141 | United States |
| Clinvest, A Division of Banyan Group, Inc. | Springfield | Missouri | 65807 | United States |
| Prarie Fields Medicine/Clinical Research Advantage | Fremont | Nebraska | 68025 | United States |
| James Meli DO Ltd (Clinical Research Advantage) | Henderson | Nevada | 89014 | United States |
| Clinical Research Advantage | Henderson | Nevada | 89052 | United States |
| PharmQuest | Greensboro | North Carolina | 27408 | United States |
| PMG Research of Winston-Salem | Winston-Salem | North Carolina | 27103 | United States |
| COR Clinical Research, LLC | Oklahoma City | Oklahoma | 73103 | United States |
| PMG Research of Bristol | Bristol | Tennessee | 37620 | United States |
| ClinSearch | Chattanooga | Tennessee | 37421 | United States |
| Nashville Neuroscience Group | Nashville | Tennessee | 37203 | United States |
| FutureSearch Trials of Neurology and Sleep Lab | Austin | Texas | 78731 | United States |
| Neurology Studies of Austin, A Division of DermResearch Inc. | Austin | Texas | 78759 | United States |
| FutureSearch Trials of Dallas | Dallas | Texas | 75231 | United States |
| Clinical Trial Network (CTN Texas) | Houston | Texas | 77074 | United States |
| Neurology & Headache Treatment Center | McLean | Virginia | 22102 | United States |
| Goadsby PJ, Dodick DW, Martinez JM, Ferguson MB, Oakes TM, Zhang Q, Skljarevski V, Aurora SK. Onset of efficacy and duration of response of galcanezumab for the prevention of episodic migraine: a post-hoc analysis. J Neurol Neurosurg Psychiatry. 2019 Aug;90(8):939-944. doi: 10.1136/jnnp-2018-320242. Epub 2019 Apr 19. |
| 25127173 | Derived | Dodick DW, Goadsby PJ, Spierings EL, Scherer JC, Sweeney SP, Grayzel DS. Safety and efficacy of LY2951742, a monoclonal antibody to calcitonin gene-related peptide, for the prevention of migraine: a phase 2, randomised, double-blind, placebo-controlled study. Lancet Neurol. 2014 Sep;13(9):885-92. doi: 10.1016/S1474-4422(14)70128-0. Epub 2014 Aug 10. |
Placebo: 0.9% Sodium Chloride, Untied States Pharmacopoeia (USP), SC injection on Day 1 and then once every other week for a total of 6 doses during the 12-week Treatment Period.
| Received at Least One Dose of Study Drug |
|
| COMPLETED |
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| NOT COMPLETED |
|
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All participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | LY2951742 | LY2951742: 150 milligrams (mg), subcutaneous (SC) injection on Day 1 and then once every other week for a total of 6 doses during the 12-week Treatment Period. |
| BG001 | Placebo | Placebo: 0.9% Sodium Chloride, USP, SC injection on Day 1 and then once every other week for a total of 6 doses during the 12-week Treatment Period. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | All participants who received at least one dose of study drug and had baseline Age data. | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Change From Baseline in the Number of Migraine Headache Days in the Last 28-day Period of the 12-week Treatment Phase | The criteria for a migraine headache was adapted from the standard International Headache Society (IHS) International Classification of Headache Disorders II guidelines 1.1 and 1.2 (ICHD-II, Cephalgia 2004). The definition of a migraine headache was a headache with or without aura, of ≥30 minutes (min) duration, and with both ("A" and "B") required features from the IHS ICHD-II definition. Required feature "A" includes at least 2 of the following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature "B" includes at least 1 of the following during the headache: nausea and/or vomiting, or photophobia and phonophobia. Least square (LS) means were calculated using mixed model repeated measures (MMRM) with baseline value, treatment, month, and treatment-by-month interaction as fixed effects and participant as random effect. | All participants with a valid 28-day baseline assessment of migraine headache days who received at least 1 dose of study treatment and had evaluable postbaseline headache data. | Posted | Least Squares Mean | Standard Error | Migraine headache days | Baseline, 12 weeks |
|
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| ||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in the Number of Headache Days in the Last 28-day Period of the 12-week Treatment Phase | Number of calendar days on which a headache lasts ≥4 hours which includes migraines, probable migraines (PM) and nonmigraines. Criteria for migraine headache (MH) was adapted from standard IHS ICHD-II guidelines 1.1 and 1.2 (Cephalgia 2004). Definition of MH was headache with or without aura, of ≥30 min duration, and with both ("A" and "B") required features from IHS ICHD-II definition. Required feature "A" includes ≥2 of following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature "B" includes at least 1 of following during headache: nausea and/or vomiting, or photophobia and phonophobia. PM is headache with or without aura, but missing 1 feature needed to fulfill all criteria for MH. LS means were calculated using MMRM with baseline value, gender, treatment, month, and treatment-by-month interaction as fixed effects and participant as random effect. | All participants with a valid 28-day baseline assessment of migraine headache days who received at least 1 dose of study treatment and had evaluable postbaseline headache data. | Posted | Least Squares Mean | Standard Error | Headache days | Baseline, 12 weeks |
| ||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in the Number of Migraine Attacks in the Last 28-day Period of the 12-week Treatment Phase | A migraine attack was defined as beginning on any day a migraine headache day was recorded and ending when a migraine headache-free day occurred. The criteria for a migraine headache was adapted from the standard IHS ICHD-II guidelines 1.1 and 1.2 (Cephalgia 2004). The definition of a migraine headache was a headache with or without aura, of ≥30 minutes duration, and with both ("A" and "B") required features from the IHS ICHD-II definition. Required feature "A" includes at least 2 of the following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature "B" includes at least 1 of the following during the headache: nausea and/or vomiting, or photophobia and phonophobia. LS means were calculated using MMRM with baseline value, gender, treatment, month, and treatment-by-month interaction as fixed effects and participant as random effect. | All participants with a valid 28-day baseline assessment of migraine headache days who received at least 1 dose of study treatment and had evaluable postbaseline headache data. | Posted | Least Squares Mean | Standard Error | Migraine attacks | Baseline, 12 weeks |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Responders | Percentage of participants with greater than 50% reduction in the number of migraine headache days in a 28-day period. The criteria for a migraine headache was adapted from the standard International Headache Society (IHS) International Classification of Headache Disorders II guidelines 1.1 and 1.2 (ICHD-II, Cephalgia 2004). The definition of a migraine headache was a headache with or without aura, of ≥30 minutes duration, and with both ("A" and "B") required features from the IHS ICHD-II definition. Required feature "A" includes at least 2 of the following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature "B" includes at least 1 of the following during the headache: nausea and/or vomiting, or photophobia and phonophobia. | All participants with a valid 28-day baseline assessment of migraine headache days who received at least 1 dose of study treatment and had evaluable postbaseline headache data during the time period of analysis. | Posted | Number | Percentage of participants | Baseline, 4, 8, and 12 weeks |
|
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All participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LY2951742 Treatment Period | LY2951742: 150 mg, SC injection on Day 1 and then once every other week for a total of 6 doses during the 12-week Treatment Period. | 0 | 107 | 36 | 107 | ||
| EG001 | Placebo Treatment Period | Placebo: 0.9% Sodium Chloride, USP, SC injection on Day 1 and then once every other week for a total of 6 doses during the 12-week Treatment Period. | 1 | 110 | 30 | 110 | ||
| EG002 | LY2951742 Posttreatment Period | LY2951742: The LY2951742 posttreatment period reporting group includes participants who received 150 mg LY2951742, completed the 12-week treatment period, and entered the posttreatment period. The posttreatment period began after Week 12 and lasted up to 12 weeks. Note: participants who discontinued early in the treatment phase did not enter the 12-week posttreatment follow-up period. | 2 | 98 | 6 | 98 | ||
| EG003 | Placebo Posttreatment Period | Placebo: The Placebo posttreatment period reporting group includes participants who received 0.9% Sodium Chloride, USP; completed the 12-week treatment period; and entered the posttreatment period. The posttreatment period began after Week 12 and lasted up to 12 weeks. Note: participants who discontinued early in the treatment phase did not enter the 12-week posttreatment follow-up period. | 3 | 103 | 2 | 103 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Peripheral vascular disorder | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
Arteaus Therapeutics executed the contracts and trial, and the Principal Investigators are restricted by any original contractual disclosure restrictions or agreements with Arteaus Therapeutics.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
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| ID | Term |
|---|---|
| C000628360 | galcanezumab |
Not provided
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|
|
|
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| Placebo |
Placebo: 0.9% Sodium Chloride, USP, SC injection on Day 1 and then once every other week for a total of 6 doses during the 12-week Treatment Period. |
|
|
Placebo: 0.9% Sodium Chloride, USP, SC injection on Day 1 and then once every other week for a total of 6 doses during the 12-week Treatment Period. |
|
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